Shanghai United Imaging Healthcare Co., Ltd.: uCT 530 Computed Tomography X-Ray System

Is my product affected?

uCT 530 Computed Tomography X-Ray System

• UPC 6971576831012

Check against the official notice below — it lists the full affected range.

What happened

Shanghai United Imaging Healthcare Co., Ltd. has recalled four uCT 530 Computed Tomography X-Ray Systems distributed to Texas due to two identified issues. The first involves a service function that may incorrectly mark a channel as faulty, resulting in ring artifacts on images. The second issue involves potential intermittent interruptions during scout scanning caused by occasional angle signal drift. The affected units have software version R001.11.0.729741-Re-1100 and specific serial numbers: 300162, 300163, 300174, and 300176.

If these problems occur, patients may need to undergo repeat scans, which would result in additional radiation exposure and potentially require additional contrast medium. The source document does not specify what remedy consumers or facilities should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

Details from the source

Reason for recall: Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium. Distribution: Distributed to Texas. Quantity: 4 units Lot/code info: Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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